Official announcements
Replacement
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Medicines
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22/08/2013
The marketing authorization holder informed its supplied customers in a letter dated August 22, 2013, that visible particles were detected in some vials and that a recall of the two affected batches will therefore be carried out.
Recall
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Medicines
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06/08/2013
B. Braun Austria Ges.m.b.H. has informed its supplied customers in a letter dated August 5, 2013, that a customer complaint has informed the marketing authorization holder about a leaking Ecoflac plus infusion container in batch 13103411. Since it…
Safety warnings
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messages in brief
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26/07/2013
Metoclopramide-containing medicinal products are approved in a number of Member States in various indications, including nausea and vomiting (for example, after chemotherapy or radiotherapy, surgery, or for migraine) and gastrointestinal motility…
messages in brief
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25/07/2013
Please note the new account number of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht: BAWAG P.S.K. AG IBAN: AT59 6000 0000 9605 1496 BIC: OPSKATWW DVR: 2112611 Inquiries: E-mail: qmgt@ages.at
Recall
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Medicines
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11/07/2013
The marketing authorization holder informed its supplied customers in a letter dated July 9, 2013, that in the course of quality assurance measures it was determined that in batch 1200758 isolated ampoules with yellowish discolored contents and thus…
Replacement
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Medicines
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04/07/2013
The distribution partner "sanofi-aventis GmbH" informed its supplied customers in a letter dated 04.07.2013 that the retained samples of the above batch showed deviations. After a storage time of 26 months, aggregates above the permissible limit of…
Safety warnings
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messages in brief
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28/06/2013
Ergot derivatives (various preparations)
messages in brief
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27/06/2013
More than 100 countries participated in this year's week of action against the illegal sale of medicines on the Internet. In total, more than nine million potentially dangerous medicines worth around 41 million US dollars were seized worldwide.…
messages in brief
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26/06/2013
Please note that, with effect from 1 July 2013, product information texts should be submitted via the PHAROS eService "Marketing Authorisation & Lifecycle Management of Medicines" on https://eservices.basg.gv.at . By then, texts and documents are no…
messages in brief
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26/06/2013
As of 02.07.2013, new regulations apply to the import of active ingredients for medicinal products for human use into the European Union. As of this date, active substances for medicinal products for human use may only be imported if at least one of…